Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medcare Disp Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
114 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841949 | DOSE RELEASE OF STERILIZATION LOTS | Medcare Disp Products, Inc. | 1984-09-05 | 114 | 0 |
| K841405 | INJECTION CAP OR ADAPTOR | Medcare Disp Products, Inc. | 1984-04-04 | 0 | 0 |
| K840924 | SYRINGE, PISTON, ARTERIAL BLOOD SAMPL | Medcare Disp Products, Inc. | 1984-03-23 | 21 | 0 |
| K821528 | SYRINGE, PISTON | Medcare Disp Products, Inc. | 1982-06-09 | 19 | 0 |
| K821529 | DISPOSABLE HYPODERMIC NEEDLES | Medcare Disp Products, Inc. | 1982-06-09 | 19 | 0 |
| K821530 | SYRINGE IRRIGATING | Medcare Disp Products, Inc. | 1982-05-28 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda